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HC device petition

PostPosted: Wed Jan 30, 2019 10:35 am
by Pat
Hi everyone, one of our members has a petition for an easier style hydrocortisone emergency injection. More details here

thanks, Pat

Re: HC device petition

PostPosted: Thu Jan 31, 2019 1:03 pm
by Carl
Thanks Pat, I saw this on Facebook and have already signed, but good to have it here too. Let's hope we get one, one day :)

Re: HC device petition

PostPosted: Wed Feb 06, 2019 3:35 pm
by KitKat
Hi Carl,

There is a prototype hydrocortisone auto injector ready to go, the Crossject Zeneo. It has been developed by a French company. ... technology
Anecdotally, I learn that it got dinged by the European Medicines Agency when it applied for orphan drug designation, on two grounds:
1. They couldn't see why it is superior to the existing Solu-Cortef Act-o-Vial or why there would be patient demand for it. (Aargh!)
2. Adrenal insufficiency is not rare enough as an umbrella condition to meet the upper threshold for a rare disease. Any of the underlying conditions causing adrenal insufficiency, eg pituitary or CAH on its own, would qualify. But combined, they are not a 'rare disease' within the EC definition.
The ceiling for a rare disease within the EMA's regulatory area is 1 in 2000 or 500 per million. There is a distinct UK definition of <30,000 for the UK as a whole.
So Rachel's petition could help support an appeal to EMA to reconsider its rejection of the Crossject Zeneo auto injector. As a warning, the Zeneo is single use and likely to cost upwards of £70 a pop, so it's likely to be reserved for paediatric use and in adults, those with poor eyesight, peripheral neuropathy or other complications that mean self-injection isn't feasible. But still worth fighting for, because it will save lives.